• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K040537
Device Name AMS APOGEE VAULT SUSPENSION SYSTEM
Original Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Original Contact elsa a linke
Regulation Number878.3300
Classification Product Code
OTP  
Date Received03/02/2004
Decision Date 04/22/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
-
-